Kornimate/medical-research-clean huggingface dataset:
evusheld assessment real world effectiveness at upmc

Conditions: SARS-CoV-2, COVID-19

Summary: an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population in the university of pittsburgh medical center (upmc) health system.

this a phase iv observational, secondary data study to assess the effectiveness of evusheld in preventing covid-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system. the study is designed as an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population in upmc health system

Eligibility criteria:
inclusion criteria: 1. receipt of evusheld under the fda eua for evusheld 2. eligibility for assess evusheld use under the eua. - exclusion criteria: * none

Keywords: evusheld, azd7442, sars-cov-2, covid-19, immunocompromise
virtual reality and autobiographical recall in anorexia nervosa: a preliminary study

Conditions: Anorexia Nervosa

Summary: clinical trial in patients with anorexia nervosa using body-swapping technique e virtual reality body size estimation tasks and autobiographic recall on sympton remission (edi-3; ede-q), body satisfaction and perception


Eligibility criteria:
inclusion criteria: * anorexia nervosa * body mass index equal or superior to 15 kg/m2 * mother tongue italian * semiresidential rehabilitation program exclusion criteria: * other eating disorders * neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders
tcups- tolvaptan use in cystinuria and urolithiasis: a pilot study

Conditions: Cystinuria

Summary: the goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study of the safety and tolerability of this drug, and assess impact on urinary stone risk parameters, among adolescent and young adult patients with clinical cystinuria.


Eligibility criteria:
inclusion criteria: * males and females age 12 - 29 years * weight ≥ 25kg (55 lbs) * confirmed cystinuria diagnosis * specific blood test levels (done within the past 6 months) exclusion criteria: * concurrent non-renal disease that might increase risk of complications due to aquaresis * liver or biliary disease (chronic or acute) * malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy * non-cutaneous malignancy within last 5 years * history of adverse reaction or allergy to tolvaptan or other arginine vasopressin v2-receptor antagonists

Keywords: cystinuria kidney stones
generic database of moderate preterm infants

Conditions: Infant, Newborn; Infant, Moderate Preterm

Summary: this is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in nichd neonatal research network (nrn) centers. the registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. the information collected is not specific to a disease or treatment (i.e., it is "generic"). data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future nrn trials.

the moderate preterm registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in nichd neonatal research network (nrn) centers. the purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants. the registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. the information collected is not specific to a disease or treatment (i.e., it is "generic"). baseline data is collected soon after admission to the nicu; outcome data is collected at the time of death or discharge from the hospital. the data collected includes information on: * demographics of mother and infant * mother's health (e.g., pregnancy history and complications) * labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery) * infant's health (gestational age, apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.) * infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized). these data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research. informed consent: as required by local irbs.

Eligibility criteria:
inclusion criteria: * gestational age 29-33 weeks * inborn infants and outborn infants admitted by 72 hours. exclusion criteria: * none

Keywords: nichd neonatal research network moderately preterm
gsd vi and gsd ix natural history

Conditions: Glycogen Storage Disease VI; GLYCOGEN STORAGE DISEASE IXa1; GLYCOGEN STORAGE DISEASE IXa2; Glycogen Storage Disease IXB; Glycogen Storage Disease IXC; GSD 9 (All Subtypes); GSD 6

Summary: collection and review of clinical information related to glycogen storage disease type vi (gsd vi) or glycogen storage disease type ix (gsd ix) generated during clinic visits.

this natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with gsd vi or gsd ix. this information will allow a more definitive description of glycogen phosphorylase (gp) and phosphorylase kinase (phk) deficiency to be developed, which will permit development of treatment strategies for these diseases. duke will be the only site where this study takes place. however, since these are rare disorders, participants who receive care at other institutions will be included. the investigators will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. prospective data collected from patient charts after enrollment will be captured as well. participant's medical records will be continually reviewed for the duration of the study. data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver and/or muscle testing, and urine and blood laboratory results.

Eligibility criteria:
inclusion criteria: * diagnosis of gsd vi or gsd ix via: * two variants in the pygl, phka1, phka2, phkg1, phkg2, or phkb gene (or one variant with evidence of disease). note: for males, one variant in the phka1 or phka2 gene is sufficient for inclusion. * deficient gp activity or phk activity per enzymology * histology as confirmed by clinician * pregnant women with a diagnosis of gsd vi or gsd ix will be included * able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative) * able to provide consent for release of medical records exclusion criteria: * unable to provide informed consent for participation for one's self or by legally authorized representative/legal guardian/parent
artificial intelligence model for traumatic cervical spinal cord injury based on radiomics and genomics

Conditions: Spinal Cord Injuries

Summary: collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. promote multi-center cooperation in spinal cord injury research: establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.


Eligibility criteria:
inclusion criteria: 1. mri diagnosis of tcsci 2. clinic diagnosis of tcsci 3. the injury site must be in cervical spinal cord 4. mri images of t2wi must be collected within 48 hours after injury 5. complete and available imaging data, clinical data, including mri, sex, age exclusion criteria: 1. spinal cord concussion and mri scans have no obvious positive performance of spinal cord 2. the quality of mri images is insufficient or there are serious motion artifacts
nirs as a continuous noninvasive monitoring system of liver/kidney graft perfusion

Conditions: Liver Failure; Kidney Failure

Summary: the aim of the investigators work is to describe the agreement between nirs and ecodoppler, as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative period in pediatric patients.

this is an observational descriptive pilot study to explore the somanetics invos® system performance. in this study the investigators will recruit a convenient number of patients, 15 patients, that will be admitted to our icu after liver/kidney transplantation, in a 6 month period. the primary endpoint will be the correlation between hepatic/renal nirs measurements and graft's artery resistance indices, as evaluated with ecodoppler. the secondary endpoints will be: * the correlation between nirs measurements and biochemical indicators of graft function (ngal for kidney transplantation and inr, sgot/sgpt, bilirubin, lactate for liver transplantation) * the correlation between nirs measurements and svo2 values

Eligibility criteria:
inclusion criteria: * all pediatric patients admitted to our icu for postoperative care after liver/kidney transplantation exclusion criteria: * obesity (bmi \> 35) * presence of a surgical plate over the graft * impossibility of probe positioning, because of surgical wound, medication or drainage * bilirubin level \> 30 mg/dl
a study to learn about prt-064040 nasal spray in healthy adult subjects

Conditions: Migraine

Summary: this trial is a phase i, single-center, randomized, double-blind, placebo-controlled study conducted in healthy chinese adult subjects. the purpose of this study is to learn about: * safety and tolerability of prt-064040 nasal spray in healthy adult subjects. * pharmacokinetics after single and multiple dose of prt-064040 nasal spray in healthy chinese adult subjects. this study is divided into two parts: * eligible subjects in part a will receive a single dose of prt-064040 nasal spray or placebo. * eligible subjects in part b will receive multiple doses of prt-064040 nasal spray or placebo, administered once daily (qd) for a total of 7 consecutive days.


Eligibility criteria:
inclusion criteria: 1. healthy male or female chinese adults aged ≥18 years and ≤55 years. 2. body mass index of 18 to 28 kg/m\^2; and a total body weight ≥50 kg for males and ≥45 kg for females. exclusion criteria: 1. history of allergy to any medications, foods, or other substances. 2. history or presence of any severe diseases that are considered clinically significant by the investigator. 3. any clinically significant abnormal laboratory test results or positive test. 4. any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product. 5. standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities. 6. pregnant or breastfeeding women, or those with a positive pregnancy test result during screening. 7. positive urine drug screen, alcohol breath test, or nicotine test. 8. history of significant alcohol abuse or drug abuse. 9. donation or loss of blood of approximately 400 ml or more within 3 months prior to dosing. 10. previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.
a study to evaluate the efficacy and tolerability of zoledronic acid in patients with metastatic prostate cancer who can be treated with a group of medications known as bisphosphonates

Conditions: Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

Summary: the purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained * age \> 18 years * histologically confirmed diagnosis of carcinoma of the prostate * current (or previous) objective evidence of metastatic disease to the bone * currently receiving 1st line hormonal therapy with lhrh agonists or other hormonal treatments * ecog performance status of 0, 1, or 2 exclusion criteria: * patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less * corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) * wbc\<3.0x1'000'000'000, anc \< 1500/mm3, hgb\<8.0 g/dl, platelets \< 75 x 1'000'000'000/l. * liver function tests \>2.5 uln, serum creatinine \>1.5 uln. * patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol. * known hypersensitivity to zoledronic acid or other bisphosphonates * subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study other protocol-defined inclusion / exclusion criteria apply.

Keywords: zoledronic acid sre prostate cancer
brain recovery with automated ventilation

Conditions: Brain Injuries, Acute; Respiration, Artificial; Automation

Summary: thus far, the closed-loop ventilation mode intellivent-asv has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ards), patients with ards, and patients with chronic obstructive pulmonary disease (copd). some of these studies included acute brain injury (abi) patients, but the effectiveness, efficacy and safety of intellivent-asv has never been thoroughly tested in these patients. the current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (intellivent-asv) in acute brain injury patients, using breath-by-breath data.

rationale: closed-loop ventilation has been proven effective in lung-protective ventilation but its effectiveness, safety and efficacy in providing both lung- and brain-protective ventilation in patients with acute brain injury has not been investigated. objective: to evaluate the effectiveness, efficacy and safety of intellivent-asv with respect to brain- and lung-protective ventilation in abi patients hypothesis: we hypothesize that intellivent-asv is effective with regard to brain- and lung-protective ventilation (that is achieving brain- and lung- protective targets), efficacious (that is improving outcomes), and that intellivent-asv is safe in invasively ventilated abi patients. study design: single-center, crossover trial. methods: in this prospective observational study, breath-by-breath ventilation data will be available from before and after the switch to closed-loop ventilation with intellivent-asv, wherein the decision to switch is determined by the attending healthcare worker, i.e., not protocolized and only for clinical/organizational reasons. high granular data are collected both before and after this switch, limited to three hours for conventional and three hours for closed-loop ventilation. neuromonitoring is part of current clinical practice and data will be collected only when available. study population: invasively ventilated patients diagnosed with acute brain injury methods: when the ventilator is switched upon the caregivers decision, data will be collected from three hours before the switch and three hours after the switch. study endpoints: the primary composite endpoint is the proportion of breaths and proportion of time within predefined zones of ventilation (based on vt and airway pressures, saturation of peripheral o2 (spo2) and end-tidal co2 (etco2).

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years; * intubated and receiving invasive ventilation for abi; * admitted to the intensive care unit exclusion criteria: - receiving ventilation with a ventilator that does not allow intellivent-asv
interval-training and appetite regulation in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: four months of interval walking (iw) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (cw) training. the reason for this is unclear. this study will assess if iw leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to cw and no exercise. subjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. trials will be identical except the following interventions: 1. one hour of rest (con) 2. one hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; iw) 3. one hour of continuous walking (cw) matched to iw with regards to energy-expenditure. after the interventions subjects will undergo a liquid mixed meal tolerance test (450 kcal), with regular measurements of appetite-related hormones (insulin, ghrelin, leptin, cholecystokinin, pyy). three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. free-living energy intake via food records will be assessed during the following 32 hours.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * bmi \> 25 exclusion criteria: * pregnancy * smoking * contraindication to increased levels of physical activity * eating disorder * insulin dependence

Keywords: exercise appetite energy intake
everolimus and letrozole as preoperative therapy of primary breast cancer in post-menopausal women

Conditions: Breast Neoplasm

Summary: the purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.


Eligibility criteria:
inclusion criteria: * histologically-confirmed diagnosis of invasive breast cancer, previously untreated * patients must be postmenopausal * candidates for mastectomy or breast-conserving surgery * primary tumor of above 2 cm diameter, measured by imaging * clinical stage m0 * who performance status ≤1 * adequate bone marrow, liver, and renal function exclusion criteria: * multicentric invasive tumors * bilateral or inflammatory breast cancer * receiving concomitant anti-cancer treatments such as chemotherapy * patients with an uncontrolled infection * patients with other concurrent severe and/or uncontrolled medical disease additional protocol-defined inclusion/exclusion criteria may apply.

Keywords: breast cancer cancer of the breast neo-adjuvant primary breast cancer postmenopausal pre-operative
high resolution thermal imaging to identify vertebral fractures in children and young people with osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: brittle bone disease also known as osteogenesis imperfecta (oi) is characterised by a defect in the bone tissue that leads to recurrent fractures and significant bone deformities in children. these fractures include vertebral (spinal) fractures. as a result, child with oi require regular clinic surveillance that includes repeated xrays of the spine. in our pilot study the investigators plan to use a thermal imaging camera that can pick up changes in temperature to 0.03 degrees to determine whether the investigators can accurately identify vertebral fractures without the need for radiation. in the first part of the study the investigators will compare the thermal images from the camera with the xrays to see if the investigators can pick up the vertebral fractures seen on the xray picture. if this is possible, then the investigators will move on to phase 2 of the study which will investigate the ability of the thermal camera to pick up vertebral fractures without prior knowledge of where the fractures are located. if this approach is successful this will help us to develop a nonradiation, lowcost painless way of identifying vertebral fractures in children with oi.


Eligibility criteria:
* patients with osteogenesis imperfecta (with known vertebral fractures)for phase one of the study. * patients with osteogenesis imperfecta for phase 2 of the study * in both groups patients will be aged 5 years and over
a longitudinal study of the trajectory of financial toxicity and its relationship with symptom burden in breast cancer patients

Conditions: Financial Toxicity

Summary: breast cancer has become the leading cause of global cancer incidence. with the improvement of treatment methods, some breast cancer patients have experienced different degrees of financial toxicity, which seriously affected the quality of life, treatment compliance and treatment outcomes of patients. currently, there are some related studies on financial toxicity in breast cancer patients, but they are mainly cross-sectional studies, lacking the use of validated financial toxicity tools to measure the longitudinal change trajectory of financial toxicity. the financial toxicity of breast cancer patients may change dynamically with the treatment stage, expenditure and time, so it is necessary to conduct a rigorously designed prospective study to explore the trajectory of financial toxicity. in addition, previous studies have showed that financial toxicity may be associated with anxiety, distress, pain and overall symptom burden. however, the relevant evidence is currently limited. this study is designed as a prospective longitudinal study to explore the trajectory of financial toxicity and its influencing factors in breast cancer patients in china, and to focus on the relationship between symptom burden and financial toxicity, which will help clinicians identify potential high-risk populations, and provide a new perspective for future intervention programs.


Eligibility criteria:
inclusion criteria: * diagnosed with breast cancer and underwent surgery * be going to receive one or more of chemotherapy, radiotherapy, targeted therapy, endocrine therapy, and immunotherapy * with the ability to understand and communicate in chinese * provided informed consent exclusion criteria: * illness was considered too severe for participation * with cognitive or psychiatric disorders